| Developers: | Nostrum Laboratories |
| Date of the premiere of the system: | January, 2021 |
| Branches: | Pharmaceutics, medicine, health care |
2021: A withdrawal of medicine because of risk of development of cancer
At the beginning of January, 2021 Nostrum Laboratories voluntarily withdraws one batch of tablets with the slowed-down hydrochloride metformin release as it was revealed that they contain excessive levels of "probable carcinogen for the person".
Metformin - widely used medicine applied at diabetes 2 types. In November, 2020 the Nostrum company withdrew two batches of tablets on 750 mg. According to the message of Management of the USA on sanitary inspection behind quality of foodstuff and medicines (FDA), during the control research it was revealed that metformin of these batches contains impurity of nitrosamines which concentration exceeds the recommended limit.
This impurity "is classified as possible carcinogen for the person (substance which can cause cancer) on the basis of results of laboratory tests. NDMA is the known pollutant of the environment and contains in water and foodstuff, including meat, dairy products and vegetables".
In particular, tablets with the prolonged release of HCI metformin, 750 mg, NDC number 29033-056-01, batch number MET200501, an expiration date were withdrawn July, 2022. Medicine was already distributed among wholesalers on all states. The company reports that the withdrawn batches can be returned to the place of purchase for a refund. FDA reminds that patients should not stop drug intake, without having consulted to the doctor, and ideally should replace metformin of Nostrum Laboratories company with medicine of other producer with the same active ingredient.
Today the Nostrum Laboratories company did not receive messages about the ghost effects connected with this response. At emergence of any problems which are perhaps connected with acceptance of this medicine, patients should contact the attending physician. In case of any questions patients can address to department of Nostrum Laboratories of medical questions.[1]
Notes
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